BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 13014769 · Received December 15, 2021

    Report

    Report Number
    2955842-2021-11754
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 11, 2021
    Report Date
    November 22, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION DID NOT REPLICATE NOR CONFIRM THE REPORTED COMPLAINT OF ¿FAILURE TO UNCLAMP¿. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, PASSED RECOGNITION AND ENGAGEMENT TESTS, AND THE GRIPS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, THE JAW CERAMIC DOTS WERE PRESENT. DURING IN-HOUSE TESTING, THE INSTRUMENT FAILED TO MOVE INTUITIVELY. THE INSTRUMENT FAILED TO FOLLOW THE MASTER TOOL MANIPULATOR (MTM) COMMAND. VISUAL INSPECTION WAS CONDUCTED AND FOUND A LOOSE SNAKE WRIST CABLE, WHICH WAS NOT RELATED TO THE REPORTED COMPLAINT. THE ROOT CAUSE WAS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE LOGS SHOWED NO FAILURES.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE VESSEL SEALER EXTEND INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TO BE PERFORMED, BUT THE INSTRUMENT HAS NOT YET BEEN RECEIVED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE HAS NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG WAS PERFORMED. PER THE REVIEW. THE INSTRUMENT WAS USED ON (B)(6) 2021 ON SYSTEM SK0499. THIS IS A SINGLE USE INSTRUMENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE COMPLAINT ACKNOWLEDGES THE GRIPS DID NOT OPEN AND/OR WERE CLAMPED AND COULD NOT BE OPENED WITH THE USE OF THE EMERGENCY GRIP RELEASE FUNCTION. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE ENDOWRIST VESSEL SEALER EXTEND FAILS TO UNCLAMP FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. FIELD IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE. THE INFORMATION FOR BLANK FIELDS IN SECTION IS NOT AVAILABLE. FIELDS ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT FAILED TO UNCLAMP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 25-NOV-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. THE ISSUE OCCURRED DURING TISSUE PREPARATION. THE ISSUE DID NOT OCCUR AFTER A SYSTEM FAULT. THE INSTRUMENT JAWS WERE NOT STUCK ON TISSUE WHEN THE ISSUE WAS IDENTIFIED. SINCE NO TISSUE WAS GRASPED, THERE WERE NO ADVERSE EFFECTS. THE INSTRUMENT WAS USED ON TISSUE DURING DISSECTION OF THE INTESTINE. THE EMERGENCY GRIP RELEASE FUNCTION WAS NOT USED AS THE INSTRUMENT JAWS WERE NOT CLAMPED ON TISSUE WHEN THE ISSUE OCCURRED. THERE WAS NO UNEXPECTED TISSUE REMOVAL AND NO UNEXPECTED BLEEDING. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT HISTORY CANNOT BE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909974 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L90210517 0162 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES